WO2021235199A1 - Balloon device - Google Patents

Abstract

A balloon device 10 comprises a shaft 11 and a plurality of linear parts 12, one end part 13 of each of which is fixed to a distal-end part of the shaft 11. The shaft 11 is inserted into an inside tube of a balloon catheter. The other-end sides of the linear parts 12 extend further toward a proximal side than the one-end parts 13 and are positioned on the outer periphery of a balloon. The linear parts 12 are formed so that, when extending along the shaft 11, the linear parts 12 are in an insertable state in which the linear parts 12 can be inserted together with the shaft 11 into the inside tube.

Description

Device for balloon Cross-reference of related applications

This application is based on Japanese Application No. 2020-087464 filed on May 19, 2020, and the contents of the description are incorporated herein by reference.

The present disclosure relates to a balloon device used for a balloon catheter.

Conventionally, balloon catheters have been used in treatments such as PTA (percutaneous angioplasty) and PTCA (percutaneous coronary angioplasty). The balloon catheter is provided with a balloon that can be expanded and contracted on its distal end side. In a balloon catheter, a balloon is introduced in a contracted state into a portion narrowed or occluded by a lesion or the like generated in a blood vessel, and then the balloon is inflated to expand the portion.

Here, if the lesion in the blood vessel is calcified or hardened, it may be difficult to expand the lesion with a balloon. Therefore, Patent Document 1 proposes a device for a balloon, which is attached to a balloon catheter to improve the expanding force of the balloon in such a case. The device of Patent Document 1 includes a long body that can be inserted into a guide wire lumen of a balloon catheter, and a wire rod having one end fixed to the distal portion of the long body and the other end extending to the proximal side. It is configured to have. This device is attached by inserting a long body from the distal side of the guide wire lumen and placing a wire rod on the outer peripheral surface of the balloon in the inserted state.

The device of Patent Document 1 is introduced into the body together with the balloon catheter in a state of being attached to the balloon catheter as described above. Then, the lesion is expanded by inflating the balloon with the device attached. In this case, when the balloon is inflated, a cut (crack) can be made in the lesion portion by the wire rod arranged on the outer peripheral surface of the balloon. Therefore, even if the lesion is hard, it is possible to easily expand the lesion by using the notch as a trigger.

JP-A-2019-129893

Here, as described above, in the device of Patent Document 1, the wire rod is arranged on the outer peripheral side of the balloon in a state of being attached to the balloon catheter. Then, in such an attached state, it is introduced into the body together with the balloon catheter. In this case, there is a concern that the wire rod may damage the tube wall in the body when the device is introduced into the body. Therefore, the device of Patent Document 1 still has room for improvement in that respect.

The present disclosure has been made in view of the above circumstances, and the main purpose of the present disclosure is to provide a balloon device capable of suppressing damage to the tube wall when introduced into the body.

To solve the above problems, the device for a balloon according to the first disclosure is a balloon catheter including a balloon that can be expanded and contracted, and a tube in which the balloon is attached to the distal end side and extends through the inside of the balloon. A shaft to be inserted into the tube, one end fixed to the distal end side of the shaft, the other end extending proximal to the one end, and the balloon. The linear portion is provided with a linear portion arranged on the outer peripheral side of the shaft, and the linear portion extends along the shaft so that the linear portion can be inserted into the tube together with the shaft. It is formed.

According to the balloon device of the present disclosure, the linear portion extends along the shaft so that it can be inserted into the tube of the balloon catheter together with the shaft. In this case, the entire device including the linear portion and the shaft can be introduced into the body (intravascular) through the tube. For example, a balloon catheter can be introduced into the body in advance, and the balloon device can be introduced into the body through the tube of the balloon catheter. For this introduction, the balloon device is introduced into the tube from the base end of the tube, and then the shaft is pushed distally until the linear portion is drawn distally from the distal end opening of the tube. Then, by pulling the shaft back to the proximal side, the linear portion is arranged on the outer peripheral side of the balloon. As described above, according to this balloon device, the device can be introduced into the body through the inside of the balloon catheter, so that it is possible to prevent the linear portion from damaging the tube wall in the body during introduction into the body. can do.

After arranging the linear part on the outer peripheral side of the balloon, the lesion part or the like is treated by inflating the balloon in the arranged state. After the treatment, the shaft is pulled proximally to remove the balloon device from the body through the tube. As a result, it is possible to prevent the linear portion from damaging the tube wall in the body even when the tube wall is removed from the body.

In the first disclosure, the balloon device of the second disclosure is formed so that at least the proximal end thereof is separated from the shaft in the natural state, and the linear portion is described more than the natural state. By bending toward the shaft side, the insertable state is established.

According to the present disclosure, when the balloon device is introduced into the body, when the linear portion is led out from the tube to the distal side, the linear portion naturally becomes a natural state and the proximal end portion of the linear portion is a shaft. Be separated from. Therefore, when the shaft is subsequently pulled back to the proximal side and the linear portion is arranged on the outer peripheral side of the balloon, it is possible to prevent the proximal end portion of the linear portion from being caught by the distal end of the tube. This makes it easier to arrange the linear portion on the outer peripheral side of the balloon.

The balloon device of the third disclosure includes, in the second disclosure, a closing means for bringing the linear portion closer to the shaft.

By the way, when the balloon device is removed from the body, the shaft is first pushed to the distal side so that the linear portion arranged on the outer peripheral side of the balloon is located distal to the distal end of the tube. Then, by pulling the shaft back to the proximal side, the linear portion is introduced into the tube from the proximal end, and then by further pulling the shaft toward the proximal side, the balloon device is removed from the body. Here, in the second disclosure, at least the proximal end of the linear portion is separated from the shaft in the natural state of the linear portion. Therefore, when the linear portion is positioned distal to the tube from the outer peripheral side of the balloon during removal, it is conceivable that a part of the linear portion is separated from the shaft. In this case, when the linear portion is introduced into the tube, it is assumed that the introduction cannot be performed well, and it may be difficult to remove the balloon device.

Therefore, in this disclosure, in view of these points, a closing means for bringing the linear portion closer to the shaft is provided. In this case, after the linear portion is positioned from the outer peripheral side of the balloon to the distal side of the tube, the linear portion can be easily introduced into the tube by bringing the linear portion closer to the shaft by a closing means. .. Thereby, the balloon device can be suitably removed while obtaining the effect of the second disclosure.

In the third disclosure, the balloon device of the fourth disclosure includes a plurality of suction members provided on the linear portion and the shaft, respectively, as the closing means, and suck each other by a suction force, and each suction thereof. The member generates the suction force by applying a generation factor that generates the suction force from the outside.

According to the present disclosure, suction members are provided on the linear portion and the shaft, respectively, and the linear portion can be brought closer to the shaft by the suction force of each of the suction members. Further, each suction member is adapted to generate a suction force by applying a generation factor that generates a suction force from the outside. In this case, when the balloon device is removed, the linear portion is positioned from the outer peripheral side of the balloon to the distal side of the tube, and then the suction force of the suction member is generated, so that the linear portion is shafted by the suction force. Can be approached to. Thereby, when the linear portion is pulled into the tube and introduced, the introduction can be facilitated.

In the third disclosure, the balloon device of the fifth disclosure includes, as the closing means, a wire rod fixed to the linear portion and extending toward the proximal side of the fixing portion, and the wire rod is provided. By being pulled to the proximal side, the linear portion is brought closer to the shaft.

According to the present disclosure, a wire rod is fixed to the linear portion, and the wire rod extends toward the proximal side of the fixed portion. In this case, by pulling the wire rod toward the proximal side, the linear portion is brought closer to the shaft. In this case as well, as in the fourth disclosure, the linear portion can be easily introduced into the tube by bringing the linear portion closer to the shaft when the balloon device is removed. Further, in this case, by pulling the wire rod to the proximal side, the entire linear portion can be brought closer to the shaft, so that the linear portion can be more easily introduced into the tube.

In the second disclosure, the balloon device of the sixth disclosure has the linear portion extending distally from the one end and the other end extending proximally from the distal end. It has a bent portion bent in such a manner, the distal end is formed by the top of the bent portion, and the linear portion is bendable at the top, and the bending thereof causes the other. By arranging the end side along the shaft, the insertable state is established.

According to the present disclosure, the linear portion extends distally from one end fixed to the shaft and is bent by the bent portion so that the other end side extends proximally to the distal end. ing. In such a configuration, when the shaft is pulled proximally from the state where the linear portion is arranged on the outer peripheral side of the balloon, the linear portion is introduced into the tube from the one end portion fixed to the shaft. Specifically, at this time, the other end side of the linear portion is inverted so that the other end portion faces the distal side, and the inverted portion is introduced into the tube. In this case, when the balloon device is removed through the tube, it can be removed with the linear portion introduced. Therefore, when the balloon device is removed, it is only necessary to pull it back to the proximal side, and the removal work can be facilitated.

Further, the linear portion can be bent at the top of the bent portion (that is, the distal end of the linear portion), and the other end side of the distal end is arranged along the shaft by the bending. It is in a state where it can be inserted. Therefore, even if the linear portion has a bent portion, the insertability of the balloon device in the tube can be suitably ensured.

In the sixth disclosure, the balloon device of the seventh disclosure has the linear portion, one end of which is fixed to the distal end surface of the shaft.

According to the present disclosure, since one end of the linear portion is fixed to the distal end surface of the shaft, the linear portion is bent at the top of the bent portion so that it can be inserted into the linear portion. One end side of the apex is located distal to the distal end of the shaft. In this case, the height of protrusion of the linear portion from the outer peripheral surface of the shaft can be suppressed as compared with the case where one end side of the linear portion is arranged on the outer peripheral surface side of the shaft. Therefore, the structure in which the linear portion has a bent portion makes it possible to suitably improve the insertability of the balloon device in the tube.

In the first disclosure, the balloon device of the eighth disclosure is such that the linear portion is in the insertable state in a natural state, and the balloon is bent toward a side away from the shaft from the natural state. It will be placed on the outer peripheral side of.

According to the present disclosure, in the natural state of the linear portion, the linear portion extends along the shaft and is in an insertable state. In this case, when the balloon device is removed, the shaft is pushed to the distal side to position the linear portion distal to the tube from the outer peripheral side of the balloon, so that the linear portion is naturally in a state where it can be inserted. Therefore, when the shaft is subsequently pulled back to the proximal side to introduce the linear portion into the tube, the introduction can be facilitated.

The balloon device of the ninth disclosure includes, in the eighth disclosure, an opening means for separating the proximal end of the linear portion from the shaft.

In the eighth disclosure above, when the balloon device is introduced into the body, when the linear portion is led out to the distal side of the tube of the balloon catheter, the linear portion remains in an insertable state. In this case, since the proximal end of the linear part is close to the shaft, it is assumed that it will be difficult to arrange the linear part on the outer peripheral side of the balloon by pulling the shaft toward the proximal side. Will be done. In that respect, according to the present disclosure, since the proximal end of the linear portion can be separated from the shaft by the closing means, the shaft is pulled toward the proximal side in the separated state to pull the linear portion of the balloon. It can be arranged on the outer peripheral side. Therefore, even if the proximal end of the linear portion is close to the shaft, the linear portion can be suitably arranged on the outer peripheral side of the balloon.

In the ninth disclosure, the balloon device of the tenth disclosure includes a plurality of repulsive members provided on the linear portion and the shaft, respectively, as the opening means, and repel each other by a repulsive force, and each of the repulsive devices is provided. The member generates the repulsive force by applying a generating factor that generates the repulsive force from the outside.

According to the present disclosure, a repulsive member is provided on each of the linear portion and the shaft, and the proximal end portion of the linear portion is separated from the shaft by the repulsive force of each of the repulsive members. Further, each repulsive member is adapted to generate a repulsive force by applying a generating factor that generates a repulsive force from the outside. In this case, when arranging the linear portion on the outer peripheral side of the balloon, after the linear portion is positioned on the distal side of the tube, the repulsive force of the repulsive member is generated, and the linear portion is generated by the repulsive force. The proximal end of the can be separated from the shaft. This makes it possible to facilitate the work of pulling the shaft to the proximal side and arranging the linear portion on the outer peripheral side of the balloon.

In any of the first to tenth disclosures of the eleventh disclosed balloon device, the linear portion is a linear portion for forming a notch used for making a notch in a lesion portion in the body.

According to the present disclosure, since the linear portion is a linear portion for forming a notch for making a notch in a lesion portion in the body, the balloon is inflated with the linear portion arranged on the outer peripheral side of the balloon. This makes it possible to make a notch in the lesion by the linear part. Therefore, even if the lesion is hard, it is possible to easily expand the lesion by using the notch as a trigger.

Further, when arranging the linear portion for forming a notch on the outer peripheral side of the balloon, the balloon device can be introduced and arranged through the inside of the balloon catheter as described above. Therefore, when the lesion cannot be sufficiently expanded by the expanding force of the balloon, the linear portion can be arranged on the outer peripheral side of the balloon while the balloon catheter is arranged in the body. In this case, since the linear portion can be arranged on the balloon without moving the balloon catheter in and out of the body, the work can be easily performed when improving the expanding force of the balloon by the linear portion.

The balloon device of the twelfth disclosure includes, in any one of the first to eleventh disclosures, a detachable portion that detachably fixes the one end portion of the linear portion to the shaft.

According to the present disclosure, since the linear portion is removable from the shaft, the linear portion can be placed on the outer peripheral side of the balloon, and then the linear portion can be removed from the shaft and placed in the body. .. Therefore, if an indwelling device such as a stent that is indwelled in the body including the detachable linear portion is configured, the device can be introduced into the body through the inside of the balloon catheter. This makes it possible to prevent the tube wall from being damaged when the indwelling device is introduced into the body.

The above objectives and other objectives, features and advantages of the present disclosure will be further clarified by the following detailed description with reference to the accompanying drawings.
The schematic whole side view which shows the structure of the device for a balloon and a balloon catheter in 1st Embodiment. A vertical sectional view showing the configuration of a balloon catheter. (A) is a side view showing the distal end side of the balloon device in the natural state of the linear portion, and (b) is a side view showing the distal end side of the balloon device in the insertable state of the linear portion. (C) is a cross-sectional view taken along the line AA of (a), and (d) is an enlarged view showing the inside of the frame B of (c). An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. The balloon device in the second embodiment is shown, (a) is a side view showing the distal end side of the balloon device in the natural state of the linear portion, and (b) is the insertion of the linear portion. It is a side view which shows the distal end side of the device for a balloon in a state, and (c) is a sectional view taken along the line CC of (a). An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. It is a side view which shows the distal end side of the balloon device in 3rd Embodiment, (a) shows the natural state of a linear part, and (b) is the state which the linear part is separated from a shaft. Shows. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. It is a side view which shows the distal end side of the device for a balloon in 4th Embodiment, (a) shows the natural state of a linear part, and (b) shows the insertable state of a linear part. There is. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. FIG. 3 is a cross-sectional view showing a cross section of a linear portion in another embodiment. A side view showing a linear portion provided with a protrusion. It is a side view which shows the distal end side of the device for a balloon, (a) shows the natural state of a linear part, and (b) shows the insertable state of a linear part. The figure for demonstrating the structure which provided the connecting part which connects a plurality of linear parts. The figure for demonstrating the connecting member interposed between one end of a linear part and a shaft. The figure which shows the structure which made the one end part of a linear part detachable with respect to a shaft.

[First Embodiment]
Hereinafter, an embodiment embodying the present disclosure will be described with reference to the drawings. In this embodiment, a balloon device used for a balloon catheter is embodied. In the following, prior to explaining the configuration of the balloon device, first, the configuration of the balloon catheter will be described with reference to FIGS. 1 and 2. FIG. 1 is a schematic overall side view showing the configurations of the balloon device 10 and the balloon catheter 20. FIG. 2 is a vertical cross-sectional view showing the configuration of the balloon catheter 20.

As shown in FIGS. 1 and 2, the balloon catheter 20 includes a catheter body 21, a hub 22 attached to a proximal end (base end) of the catheter body 21, and a distal end side of the catheter body 21 (as shown in FIG. It is provided with a balloon 23 attached to the tip side). The catheter body 21 includes an outer tube 25 and an inner tube 26 inserted inside the outer tube 25, and has a double tube structure formed by both tubes 25 and 26.

The outer tube 25 is formed in a tubular shape made of a resin material, and has a lumen 25a extending in the entire axial direction inside the outer tube 25. The proximal end of the outer tube 25 is connected to the hub 22, and the distal end of the outer tube 25 is joined to the proximal end of the balloon 23. The lumen 25a of the outer tube 25 leads to the inner space of the balloon 23. The lumen 25a of the outer tube 25 is a fluid lumen through which the compressed fluid flows when the balloon 23 is expanded or contracted.

The inner tube 26 is formed in a tubular shape made of a resin material, and has a lumen 26a extending in the entire axial direction inside the inner tube 26. The proximal end of the inner tube 26 is connected to the hub 22. The inner tube 26 extends toward the tip end side of the outer tube 25, and the extending portion is covered from the outside by the balloon 23. That is, the inner tube 26 extends through the inside of the balloon 23, and its distal end side is joined to the distal end of the balloon 23. The inner tube 26 corresponds to a "tube".

The lumen 26a of the inner tube 26 is a lumen for the guide wire through which the guide wire G is inserted. The lumen 26a of the inner tube 26 extends proximally from the distal end of the balloon catheter 20 to the hub 22. In this case, the proximal end opening of the lumen 26a is formed at the proximal end of the catheter body 21. Therefore, the balloon catheter 20 is a so-called over-the-wire type catheter.

The balloon 23 is formed of a thermoplastic polyamide elastomer. However, the balloon 23 may be formed of another thermoplastic resin such as polyethylene or polypropylene. The balloon 23 has its proximal end joined to the outer tube 25 and its distal end joined to the inner tube 26. The balloon 23 has an inflatable portion that can be expanded and contracted between both ends joined to the tubes 25 and 26. When the compressed fluid is supplied to the inside of the balloon 23 through the lumen 25a of the outer tube 25, the balloon 23 (specifically, the inflated portion) is in an inflated state. Further, when a negative pressure is applied to the lumen 25a of the outer tube 25 and the compressed fluid is discharged from the inside of the balloon 23, the balloon 23 is in a contracted state.

The hub 22 is formed in a Y shape by a resin material, and has a first pipe portion 28 and a second pipe portion 29 branched from the first pipe portion 28. The first pipe portion 28 has a pipe hole 28a extending over the entire axial direction, and the pipe hole 28a communicates with the pipe hole 29a of the second pipe portion 29 at an intermediate position thereof.

The outer tube 25 and the inner tube 26 are inserted into the tube hole 28a of the first tube portion 28 from the tip end side thereof. Each of these tubes 25 and 26 is joined to the first tube portion 28 in the inserted state. The lumen 25a of the outer tube 25 communicates with the tube hole 29a of the second tube portion 29 via the tube hole 28a of the first tube portion 28. As a result, by connecting a fluid supply device (not shown) such as a pressurizer to the second tube portion 29, it is possible to supply the compressed fluid from the device into the balloon 23 through the tube hole 28a and the lumen 25a. It has become. Further, the lumen 26a of the inner tube 26 is opened to the proximal end side of the hub 22 via the tube hole 28a.

Subsequently, the configuration of the balloon device 10 will be described with reference to FIG. 3 in addition to FIG. 3A and 3B are side views showing the distal end side of the balloon device 10. (A) shows the natural state of the linear portion 12 constituting the balloon device 10, and (b) shows the insertable state of the linear portion 12. Further, FIG. 3C is a sectional view taken along line AA of FIG. 3A, and FIG. 3D is an enlarged view showing the inside of the frame B of FIG. 3C in an enlarged manner.

As shown in FIGS. 1 and 3A, the balloon device 10 includes a shaft 11 and a linear portion 12 fixed to the distal end of the shaft 11. The shaft 11 is formed in a tubular shape by a resin material, and more specifically, in a circular tubular shape. The shaft 11 has a pipe hole 11a extending over the entire axial direction. The tube hole 11a is used as a lumen for the guide wire through which the guide wire G is inserted. The shaft 11 does not necessarily have to be formed of a resin material, and may be formed of another material such as a metal material.

The shaft 11 is inserted into the inner tube 26 (specifically, the lumen 26a thereof) of the balloon catheter 20, and its outer diameter is smaller than the inner diameter of the inner tube 26. Further, the shaft 11 has a length dimension sufficiently longer than the length of the inner tube 26. Therefore, when the shaft 11 is inserted into the inner tube 26, a part of the shaft 11 is brought out to the proximal end side of the inner tube 26 and further to the proximal end side of the hub 22.

The linear portion 12 is arranged on the outer peripheral side of the balloon 23 of the balloon catheter 20, and is used to make a notch in the lesion portion when the balloon 23 is inflated to expand the lesion portion. As a result, when the lesion is hardened due to calcification or the like, it is possible to make a cut in the lesion so that the lesion can be easily expanded by using the cut as a trigger. A plurality of linear portions 12 are arranged at predetermined intervals (specifically, at equal intervals) in the circumferential direction of the shaft 11. In the present embodiment, three linear portions 12 are arranged, and all of these linear portions 12 have the same configuration. The linear portion 12 corresponds to the “linear portion for forming a notch”.

The linear portion 12 is linearly formed of a flexible metal material and is formed of, for example, a superelastic alloy such as nickel titanium (Ni—Ti). The linear portion 12 is formed to be thinner than the shaft 11, and its length is longer than the axial length of the balloon 23. The linear portion 12 may be formed of a metal material other than the superelastic alloy, or may be formed of a material other than the metal material such as a hard resin. That is, as long as the linear portion 12 is a flexible material, the material may be arbitrary.

One end portion 13 of the linear portion 12 is fixed to the distal end surface (tip surface) of the shaft 11 by adhesion or the like. In this case, one end portion 13 of the linear portion 12 is a fixed end portion with respect to the shaft 11, and is hereinafter referred to as a fixed end portion 13. The other end side of the linear portion 12 extends proximally to the fixed end portion 13, and the other end portion 14 is a free end. The other end 14 of the linear portion 12 constitutes a proximal end portion of the linear portion 12, and is hereinafter referred to as a proximal end portion 14.

The linear portion 12 has a bent portion 15 on the fixed end portion 13 side thereof. The bent portion 15 is formed to be bent so as to be convex toward the distal side, and more specifically, the bent portion 15 is formed to be curved. In this case, the linear portion 12 extends from the fixed end portion 13 toward the distal side, and is bent by the bending portion 15 so that the proximal end portion 14 side of the distal end extends toward the proximal side. .. The bent portion 15 may be bent instead of curved.

In the bent portion 15, the top portion 15a constituting the distal end portion constitutes the distal end of the linear portion 12. In the following, in the linear portion 12, the fixed end portion 13 side from the top portion 15a is referred to as the first portion 12a, and the proximal end portion 14 side from the top portion 15a is referred to as the second portion 12b. The bent portion 15 is bent so that the first portion 12a and the second portion 12b are aligned in the radial direction of the shaft 11. Therefore, when the linear portion 12 is viewed from one side in the axial direction of the shaft 11, the linear portion 12 extends outward along the radial direction from the shaft 11.

The second portion 12b of the linear portion 12 extends proximally from the top portion 15a of the bent portion 15 and has a curved shape that is gently convex toward the radial outer side of the shaft 11 as a whole. The second portion 12b is arranged radially outside the shaft 11 so as to be separated from the shaft 11. Therefore, the proximal end 14 of the second portion 12b is also separated from the shaft 11. In this case, the separation distance between the proximal end portion 14 and the shaft 11 is made larger than the thickness of the inner tube 26. Further, the distance between the proximal end portion 14 and the central axis of the shaft 11 is made larger than the radius of the inner tube 26.

As shown in FIGS. 3 (c) and 3 (d), the linear portion 12 has a triangular cross section (specifically, a cross section orthogonal to the length direction of the linear portion 12). Therefore, the linear portion 12 has three surfaces 18a to 18c extending in the length direction. Of these surfaces 18a to 18c, the surface 18a facing the shaft 11 side is an arrangement surface 18a arranged on the outer peripheral surface of the balloon 23. In FIG. 3C, the outer peripheral surface of the balloon 23 is shown by a two-dot chain line for reference.

Of the surfaces 18a to 18c, the top portion 17 formed by the surfaces 18b and 18c other than the arrangement surface 18a protrudes outward in the radial direction of the shaft 11. The apex 17 is used to make a notch in the lesion when treating the lesion. In the present embodiment, the angle α formed by the top portion 17 (specifically, the angle formed by the surfaces 18b and 18c) is an obtuse angle, for example, 100 ° to 120 °. More specifically, the cross section of the linear portion 12 has an isosceles triangle shape in which the widths of the surfaces 18b and 18c forming the obtuse-angled top portion 17 are equal. As a result, in the linear portion 12, the width L1 of the arrangement surface 18a is larger than the length L2 (in other words, the distance between the arrangement surface 18a and the top 17) in the direction orthogonal to the arrangement surface 18a (in other words, the distance between the arrangement surface 18a and the top 17). L1> L2).

As shown in FIG. 3 (b), the linear portion 12 can be in a state of extending along the shaft 11 by bending toward the shaft 11 from the natural state (state of FIG. 3 (a)). It has become. In the balloon device 10, each linear portion 12 is in this state, so that each linear portion 12 can be inserted into the inner tube 26 of the balloon catheter 20 together with the shaft 11. In the following description, the state in which the linear portion 12 can be inserted into the inner tube 26 is referred to as an insertable state. The natural state of the linear portion 12 means a state of the linear portion 12 when no external force is applied to the linear portion 12.

In the insertable state of the linear portion 12, the linear portion 12 is folded back at the top portion 15a of the bent portion 15, and the folded portion causes the first portion 12a and the second portion 12b to overlap each other in the radial direction of the shaft 11. It is said to be in a state of being. In this case, the first portion 12a and the second portion 12b are in a state of extending along the axial direction of the shaft 11, and the arrangement surface 18a of the second portion 12b is in contact with the outer peripheral surface of the shaft 11. Further, in the insertable state of each linear portion 12, when a virtual circle circumscribing each of the linear portions 12 is assumed, the diameter of the virtual circle is smaller than the inner diameter of the inner tube 26.

Next, the operation of the above-mentioned balloon device 10 will be described. Here, when the lesion portion is expanded by using the balloon catheter 20, the balloon device 10 is used together with the balloon catheter 20, and the operation in that case will be described below with reference to FIGS. 4 and 5. 4 and 5 are for explaining a series of steps of expanding the lesion using the balloon catheter 20 and the balloon device 10 and removing the balloon device 10 from the body after expansion. It is an explanatory diagram of.

First, a guiding catheter is inserted into the sheath introdisa inserted into the blood vessel, and the guiding catheter is introduced to just before the lesion 38 generated in the body. Next, the guide wire G is inserted into the guiding catheter, and the inserted guide wire G is introduced to a position beyond the lesion 38. Subsequently, the guide wire G is inserted into the inner tube 26 of the balloon catheter 20, and the balloon catheter 20 is introduced into the guiding catheter along the inserted guide wire G. After the introduction, the balloon 23 is placed on the lesion 38 while performing a push-pull operation. When introducing the balloon catheter 20, the balloon 23 is kept in a contracted state.

Subsequently, as shown in FIG. 4A, the lesion portion 38 is expanded by inflating the balloon 23. Here, in the example of FIG. 4A, the lesion portion 38 is calcified and hardened, which makes it difficult to sufficiently expand the lesion portion 38. Therefore, in the following, the balloon device 10 will be used to improve the expansion force of the balloon 23, and the work procedure in that case will be described below.

First, as shown in FIG. 4 (b), the balloon 23 is brought into a contracted state. As a result, a predetermined gap 39 is formed between the outer peripheral surface of the balloon 23 and the lesion 38.

Subsequently, each linear portion 12 of the balloon device 10 is placed in an insertable state (state of FIG. 3B), and the balloon device 10 is introduced into the inner tube 26 of the balloon catheter 20 from the proximal end side in that state. At this time, the balloon device 10 is introduced into the inner tube 26 via the tube hole 28a of the hub 22. Further, at the time of this introduction, the guide wire G is inserted into the tube hole 11a of the shaft 11, and the balloon device 10 is introduced into the inner tube 26 in the inserted state.

After introducing the balloon device 10 into the inner tube 26, the shaft 11 of the balloon device 10 is pushed to the distal side in the introduced state. As the push toward the distal side is advanced, the distal end side of the balloon device 10 is eventually led out from the distal end opening of the inner tube 26, as shown in FIG. 4 (c). Then, as the pushing is further advanced, as shown in FIG. 4D, each linear portion 12 of the balloon device 10 is led out to the distal side of the inner tube 26. As a result, each linear portion 12 naturally changes from the insertable state to the natural state (state of FIG. 3A). Therefore, in this case, the proximal end portion 14 of each linear portion 12 is in a state of being separated from the shaft 11.

Next, as shown in FIG. 5 (e), by pulling back the shaft 11 to the proximal side, the work of arranging each linear portion 12 on the outer peripheral side of the balloon 23 is performed. In this case, each linear portion 12 is arranged on the outer peripheral side of the balloon 23 through the gap 39 between the balloon 23 and the lesion portion 38. As a result, each linear portion 12 is attached to the outer peripheral surface of the balloon 23. Further, when the linear portion 12 is arranged on the outer peripheral surface of the balloon 23, since the proximal end portion 14 of the linear portion 12 is separated from the shaft 11, the proximal end of each linear portion 12 is arranged. The portion 14 can be prevented from being caught on the distal end of the inner tube 26. Therefore, it is possible to facilitate the work of arranging each linear portion 12 on the outer peripheral side of the balloon 23.

Next, as shown in FIG. 5 (f), the lesion 38 is expanded by inflating the balloon 23. In this case, the expansion of the balloon 23 presses each linear portion 12 against the lesion 38, whereby the linear portions 12 make a cut (crack) in the lesion 38. Therefore, the lesion 38 can be suitably expanded by using the notch as a trigger.

Next, as shown in FIG. 5 (g), the balloon 23 is brought into a contracted state. As a result, each linear portion 12 is displaced toward the shaft 11 and returns to the natural state.

Next, as shown in FIG. 5 (h), each linear portion 12 is introduced into the inner tube 26 by pulling the shaft 11 back to the proximal side. In this case, each linear portion 12 is introduced into the inner tube 26 from its fixed end portion 13. Specifically, in this case, each linear portion 12 is introduced into the inner tube 26 in an inverted state in which the second portion 12b is inverted so that the proximal end portion 14 faces the distal side. After introducing each linear portion 12 into the inner tube 26, the shaft 11 is pulled proximally in the introduced state, and the balloon device 10 is removed from the body.

When removing the balloon device 10 in this way, each line is simply pulled back to the proximal side from the state where each linear portion 12 is arranged on the outer peripheral side of the balloon 23 (see FIG. 5 (g)). The shaped portion 12 can be introduced into the inner tube 26, and the device 10 can be removed in the introduced state. Therefore, it is possible to facilitate the work of removing the balloon device 10.

After removing the balloon device 10, the balloon catheter 20 is removed from the body. This completes a series of work.

According to the configuration of the present embodiment described in detail above, the following excellent effects can be obtained.

Each linear portion 12 of the balloon device 10 is formed so as to extend along the shaft 11 so that it can be inserted into the inner tube 26 of the balloon catheter 20 together with the shaft 11. In this case, the balloon device 10 can be introduced into the body through the inner tube 26 of the balloon catheter 20 previously introduced into the body. Then, at the time of introduction, each linear portion 12 can be arranged on the outer peripheral side of the balloon 23 by pushing and pulling the shaft 11. As a result, when the balloon device 10 is introduced into the body, it is possible to prevent the linear portion 12 from damaging the tube wall in the body.

Further, when the lesion portion 38 cannot be sufficiently expanded by the expanding force of the balloon 23, the linear portion 12 is arranged on the outer peripheral side of the balloon 23 while leaving the balloon 23 (balloon catheter 20) in the body. be able to. In this case, since the linear portion 12 can be arranged on the balloon 23 without moving the balloon 23 in and out of the body, the work can be easily performed when improving the expanding force of the balloon 23 by the linear portion 12. Can be done. In particular, when the balloon 23 is taken in and out, it is necessary to align the balloon 23 with the lesion 38 again, and it may take a lot of time and effort to align the balloon 23. Therefore, the balloon is left in the body. It is significant that the linear portion 12 can be arranged on the 23.

The linear portion 12 can be bent at the top portion 15a of the bent portion 15, and the proximal end portion 14 side of the distal end is arranged along the shaft 11 by the bending, so that the linear portion 12 can be inserted. .. Thereby, even if the linear portion 12 has the bent portion 15, the insertability of the balloon device 10 in the inner tube 26 can be suitably ensured.

Specifically, since the fixed end portion 13 of the linear portion 12 is fixed to the distal end surface of the shaft 11, when the linear portion 12 is bent at the top portion 15a of the bent portion 15 to be in an insertable state. , The fixed end 13 side of the linear portion 12 with respect to the apex 15a is arranged distal to the distal end of the shaft 11. In this case, the protrusion height of the linear portion 12 from the outer peripheral surface of the shaft 11 can be suppressed as compared with the case where the fixed end portion 13 side of the linear portion 12 is arranged on the outer peripheral surface side of the shaft 11 with respect to the top portion 15a. can. Therefore, the linear portion 12 has a bent portion 15, and the insertability of the balloon device 10 in the inner tube 26 can be suitably improved.

Since the width L1 of the arrangement surface 18a arranged on the outer peripheral surface of the balloon 23 in the linear portion 12 is larger than the length L2 in the direction orthogonal to the arrangement surface 18a in the linear portion 12, the linear portion 12 Can be arranged in a stable state when the balloon 23 is arranged on the outer peripheral surface of the balloon 23.

[Second Embodiment]
Subsequently, the second embodiment will be described. In this embodiment, the configuration of the balloon device is different from that of the first embodiment. Therefore, in the following, the configuration of the balloon device in the present embodiment will be described with reference to FIG. 6, focusing on the differences from the first embodiment. In FIG. 6, (a) and (b) are side views showing the distal end side of the balloon device 30 in the present embodiment, and (a) shows the natural state of the linear portion 32. b) indicates a state in which the linear portion 32 can be inserted. Further, in FIG. 6, (c) is a sectional view taken along line CC of (a).

As shown in FIG. 6A, the balloon device 30 of the present embodiment includes a shaft 31 and a plurality of (specifically, three) linear portions 32. Since the shaft 31 has the same configuration as the shaft 11 in the first embodiment, the description thereof is omitted here. On the other hand, the linear portion 32 has a different configuration from the linear portion 12 in the first embodiment. One end 33 of the linear portion 32 is fixed to the distal end portion of the shaft 31. In this case, one end 33 of the linear portion 32 is a fixed end portion with respect to the shaft 31, and is hereinafter referred to as a fixed end portion 33. The fixed end 33 of the linear portion 32 is fixed to the outer peripheral surface of the shaft 31. Specifically, the fixed end 33 of the linear portion 32 is fixed to the outer peripheral surface of the shaft 31 on the outer peripheral surface thereof.

The linear portion 32 extends from the fixed end portion 33 to the proximal side, and the proximal end portion 34 thereof is a free end. The linear portion 32 has a curved shape that is gently convex toward the radial outer side of the shaft 31 as a whole, and a portion other than the fixed end portion 33 is separated from the shaft 31. Therefore, the proximal end 34 of the linear portion 32 is also separated from the shaft 31.

As shown in FIG. 6 (b), each linear portion 32 can be in a state of extending along the shaft 31 by bending toward the shaft 31 from the natural state (state of FIG. 6 (a)). It has become. Then, each linear portion 32 is in an insertable state so that it can be inserted into the inner tube 26 together with the shaft 31 in such a state. In the insertable state of each linear portion 32, each linear portion 32 is in a state of extending along the shaft 31 over the entire length direction. Further, in this case, each linear portion 32 is arranged in a state of being in contact with the outer peripheral surface of the shaft 31.

The shaft 31 and the linear portion 32 are provided with suction members 36 and 37 that suck each other by a magnetic force (corresponding to a suction force), respectively. The attractive members 36 and 37 are made of a magnetic material, and are magnetized to generate a magnetic force when a magnetic field (corresponding to a generating factor) is applied from the outside. Of the suction members 36 and 37, the suction member 36 is provided on the shaft 31, and the suction member 37 is provided on each linear portion 32.

As shown in FIGS. 6A and 6C, the suction member 36 is formed in a cylindrical shape and is attached to the outer peripheral surface of the shaft 31. The suction member 36 is arranged (slightly) proximally to the proximal end 34 of the linear portion 32 in the axial direction of the shaft 31. On the other hand, the suction member 37 is attached to the proximal end portion 34 of each linear portion 32, respectively. Each suction member 37 is located (slightly) distal to the suction member 36 in the axial direction of the shaft 31. However, each suction member 37 may be at the same position as the suction member 36 in the axial direction of the shaft 31.

When a magnetic field is applied to each of the suction members 36 and 37 from the outside, the suction members 36 and 37 are magnetized and a magnetic force is generated as described above. In this case, the attractive members 36 and 37 are attracted to each other by the magnetic force, whereby the proximal end portion 34 of the linear portion 32 is brought closer to the shaft 31. Therefore, in this case, the closing means is configured by the suction members 36 and 37. In the insertable state of each linear portion 32, each suction member 37 is arranged at the same position as the suction member 36 in the axial direction of the shaft 31, and more specifically, is arranged on the proximal side of the suction member 36 (FIG. 6 (FIG. 6). b) See). In this case, each suction member 37 is arranged so as to overlap the suction member 36.

Next, the operation of the balloon device 30 described above will be described with reference to FIGS. 7 and 8. 7 and 8 are explanations for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 30 and the work of removing the balloon device 30 from the body after the expansion. It is a figure.

First, each linear portion 32 of the balloon device 30 is made insertable, and the balloon device 30 is introduced into the inner tube 26 of the balloon catheter 20 in that state. After the introduction, the shaft 31 is pushed to the distal side, and as shown in FIG. 7A, each linear portion 32 is led out to the distal side from the distal end opening of the inner tube 26. As a result, each linear portion 32 changes from an insertable state to a natural state, and the proximal end portion 34 of each linear portion 32 is separated from the shaft 31.

Next, as shown in FIG. 7B, the shaft 31 is pulled back to the proximal side to arrange each linear portion 32 on the outer peripheral side of the balloon 23. As a result, as shown in FIG. 7 (c), each linear portion 32 is attached to the outer peripheral surface of the balloon 23. Further, in this arrangement, since the proximal end portion 34 of the linear portion 32 is separated from the shaft 31, it is easy to arrange each linear portion 32 on the outer peripheral side of the balloon 23.

In the state where each linear portion 32 is arranged on the balloon 23, the proximal end portion 34 of each linear portion 32 is located slightly proximal to the proximal end portion of the balloon 23. Further, the suction member 37 provided on the proximal end 34 and the suction member 36 provided on the shaft 31 are also located slightly proximal to the proximal end of the balloon 23. In this case, the suction member 36 is arranged inside the inner tube 26 (and thus inside the catheter body 21) together with the shaft 31, but in FIG. 7 (c), the suction member 36 is shown by a dot hatch for easy understanding (described later). The same applies to FIG. 7 (d).

Next, a magnetic field is generated by a magnetic field generator (not shown) prepared in advance, and a magnetic field is applied to the suction members 36 and 37. As a result, a magnetic force is generated from the suction members 36 and 37, and the magnetic force brings the proximal end portion 34 of each linear portion 32 closer to the shaft 31 side. Specifically, in this case, since the shaft 31 (and the suction member 36) is arranged inside the catheter body 21, the proximal end portion 34 of the linear portion 32 is brought closer to the catheter body 21, and the catheter body 21 (and the catheter body 21 () Specifically, it is in a state of being fixed to the outer peripheral surface of the outer tube 25). As a result, each linear portion 32 is fixed to the outer peripheral surface of the balloon 23.

Next, as shown in FIG. 7 (d), the lesion 38 is expanded by inflating the balloon 23. In this case, each linear portion 32 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger. Further, since each linear portion 32 is fixed to the balloon 23 when the balloon 23 is inflated, it is possible to prevent the linear portions 32 from being displaced on the balloon 23.

After expanding the lesion 38, stop the generation of the magnetic field by the magnetic field generator. As a result, the suction members 36 and 37 are in a state where no magnetic force is generated, and the fixing of the linear portions 32 to the balloon 23 is released. After that, as shown in FIG. 8 (e), the balloon 23 is brought into a contracted state. Then, by pushing the shaft 31 toward the distal side, each linear portion 32 is positioned distal to the inner tube 26 from the outer peripheral side of the balloon 23. As a result, each linear portion 32 is in a natural state.

Next, by applying a magnetic field to each of the suction members 36 and 37 again by the magnetic field generator, a magnetic force is generated in each of the suction members 36 and 37. As a result, as shown in FIG. 8 (f), the proximal end portion 34 of the linear portion 32 is brought closer to the shaft 31 by the generated magnetic force, and is fixed to the shaft 31 via the suction members 36 and 37. Further, at this time, the linear portion 32 is in a state of extending along the shaft 31, that is, in an insertable state (state of FIG. 6B).

Next, as shown in FIG. 8 (g), each linear portion 32 is introduced into the inner tube 26 by pulling back the shaft 31 toward the proximal side. In this case, each linear portion 32 is introduced from the proximal end portion 34 into the inner tube 26. Then, in such an introduced state, the shaft 31 is pulled toward the proximal side to remove the balloon device 30.

Here, when each linear portion 32 is introduced into the inner tube 26, since the proximal end portion 34 of each linear portion 32 is brought close to the shaft 31, each linear portion 32 is inside from the proximal end portion 34. It is easy to introduce into the tube 26. Therefore, the balloon device 30 can be suitably removed.

When the linear portion 32 is brought closer to the shaft 31 by the magnetic force of each of the suction members 36 and 37, the linear portion 32 does not necessarily have to be in an insertable state, for example, the proximal end of the linear portion 32. Only the portion 34 may be brought close to the shaft 31. Even in that case, each linear portion 32 can be easily introduced into the inner tube 26. Further, in this case, after each linear portion 32 is introduced into the inner tube 26, it is pressed against the inner peripheral surface of the tube 26 so that it can be inserted.

According to the configuration of the present embodiment described above, the balloon device 30 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first embodiment. Therefore, when the balloon device 30 is introduced into the body, it is possible to prevent the linear portion 32 from damaging the tube wall in the body.

[Third Embodiment]
Next, a third embodiment will be described. In this embodiment, the configuration of the balloon device is different from that of the first embodiment. Hereinafter, the configuration of the balloon device in the present embodiment will be described with reference to FIG. 9, focusing on the differences from the first embodiment. 9A and 9B are side views showing the distal end side of the balloon device 40 in the present embodiment, in which FIG. 9A shows the natural state of the linear portion 42, and FIG. 9B shows the linear portion 42. Indicates a state separated from the shaft 41.

As shown in FIG. 9A, the balloon device 40 of the present embodiment includes a shaft 41 and a plurality of (specifically, three) linear portions 42. Since the shaft 41 has the same configuration as the shaft 11 in the first embodiment, the description thereof is omitted here. The linear portion 42 extends linearly along the shaft 41, and the distal end portion 43 which is one end thereof is fixed to the distal end portion of the shaft 41, and the proximal end portion 44 which is the other end portion is fixed. Is the free end. The linear portion 42 is in contact with the outer peripheral surface of the shaft 41 over the entire length direction.

In the above state (natural state) in which each linear portion 42 extends along the shaft 41, each linear portion 42 can be inserted into the inner tube 26 together with the shaft 41. Therefore, in the balloon device 40, when each linear portion 42 is in a natural state, each linear portion 42 can be inserted into the inner tube 26 together with the shaft 41.

The shaft 41 and the linear portion 42 are provided with repulsive members 46 and 47 that repel each other by a magnetic force (corresponding to a repulsive force), respectively. The repulsive members 46 and 47 are made of a magnetic material, and when a magnetic field is applied from the outside, they are magnetized to generate a magnetic force (corresponding to a factor that generates a repulsive force). Of the repulsive members 46 and 47, the repulsive member 46 is provided on the shaft 41, and the repulsive member 47 is provided on each linear portion 42, respectively.

The repulsive member 46 is formed in a cylindrical shape and is attached to the outer peripheral surface of the shaft 41. The repulsive member 46 is arranged at the same position as the proximal end portion 44 of the linear portion 42 in the axial direction of the shaft 41. On the other hand, the repulsive member 47 is attached to the proximal end portion 44 of each linear portion 42, respectively. Each repulsive member 47 is arranged at the same position as the repulsive member 46 in the axial direction of the shaft 41.

When a magnetic field is applied to the repulsive members 46 and 47 from the outside, the repulsive members 46 and 47 are magnetized and a magnetic force is generated as described above. In this case, the repulsive members 46 and 47 are repelled from each other by the magnetic force, whereby the proximal end portion 44 of the linear portion 42 is separated from the shaft 41 as shown in FIG. 9B. Specifically, in this case, the linear portion 42 bends toward the side away from the shaft 41, and substantially the entire linear portion 42 is separated from the shaft 41. In this case, the opening means is composed of the repulsive members 46 and 47.

Next, the operation of the balloon device 40 described above will be described with reference to FIGS. 10 and 11. 10 and 11 are descriptions for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 40 and the work of removing the balloon device 40 from the body after the expansion. It is a figure.

First, the balloon device 40 is introduced into the inner tube 26 of the balloon catheter 20. In this case, since each linear portion 42 is in a state in which it can be inserted in a natural state, the balloon device 40 may be introduced into the inner tube 26 as it is, and it is easy to introduce the balloon device 40. After the introduction, by pushing the shaft 41 toward the distal side, as shown in FIG. 10A, each linear portion 42 is led out to the distal side from the distal end opening of the inner tube 26. In this case, each linear portion 42 is led out from the inner tube 26 in an insertable state (natural state). Therefore, the proximal end 44 of each linear portion 42 is in contact with the shaft 41.

Next, a magnetic field is generated by a magnetic field generator (not shown) prepared in advance, and a magnetic field is applied to the repulsive members 46 and 47. As a result, as shown in FIG. 10B, a magnetic force is generated from the repulsive members 46 and 47, and the magnetic force causes the proximal end portion 44 of each linear portion 42 to be separated from the shaft 41.

Next, as shown in FIG. 10 (c), each linear portion 42 is arranged on the outer peripheral side of the balloon 23 by pulling back the shaft 41 toward the proximal side. As a result, as shown in FIG. 10D, each linear portion 42 is attached to the outer peripheral side of the balloon 23. Further, in this arrangement, since the proximal end portion 44 of the linear portion 42 is separated from the shaft 41, it is possible to easily arrange each linear portion 42 on the outer peripheral side of the balloon 23. After arranging each linear portion 42 on the balloon 23, the generation of the magnetic field by the magnetic field generator is stopped. As a result, the repulsive members 46 and 47 are in a state where no magnetic force is generated.

Next, as shown in FIG. 11 (e), the lesion 38 is expanded by inflating the balloon 23. As a result, each linear portion 42 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger.

Next, as shown in FIG. 11 (f), the balloon 23 is brought into a contracted state. Then, by pushing the shaft 41 toward the distal side, each linear portion 42 is positioned from the outer peripheral side of the balloon 23 to the distal side of the inner tube 26. In this case, each linear portion 42 is in a natural state, that is, in an insertable state.

Next, as shown in FIG. 11 (g), each linear portion 42 is introduced into the inner tube 26 by pulling back the shaft 41 toward the proximal side. In this case, since each linear portion 42 is in an insertable state, each linear portion 42 can be introduced into the inner tube 26 simply by pulling back the shaft 41 as it is. Therefore, the introduction can be facilitated. After introducing each linear portion 42, the shaft 41 is pulled toward the proximal side in the introduced state, and the balloon device 40 is removed.

According to the configuration of the present embodiment described above, the balloon device 40 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first and second embodiments. Therefore, when the balloon device 40 is introduced into the body, it is possible to prevent the linear portion 42 from damaging the tube wall in the body.

[Fourth Embodiment]
Next, a fourth embodiment will be described. In the second embodiment, the balloon device 30 is provided with suction members 36 and 37 as closing means, but in the present embodiment, the configuration of the closing means is different from that of the second embodiment. Therefore, in the following, the configuration of the balloon device in the present embodiment will be described with reference to FIG. 12, focusing on such differences. Note that FIG. 12 is a side view showing the distal end side of the balloon device 50 in the present embodiment, in which (a) shows the natural state of the linear portion 32 and (b) is the linear portion 32. Indicates the insertable state of.

As shown in FIG. 12A, the balloon device 50 of the present embodiment includes a shaft 31 and a plurality of linear portions 32. The shaft 31 and each linear portion 32 have the same configuration as the shaft 31 and each linear portion 32 of the balloon device 30 in the second embodiment. Therefore, the same reference numerals as those of the shaft 31 and the linear portion 32 of the balloon device 30 are given here, and the description of each of the portions 31 and 32 is omitted. Further, in the following, the description of each part of the linear portion 32 will be omitted with the same reference numerals as those of the second embodiment.

A wire rod 51 as a closing means is attached to each of the proximal end portions 34 of each linear portion 32. The wire rod 51 is formed to have flexibility and strength to withstand a certain amount of tensile force. The wire rod 51 is made of, for example, a thread (suture), and more specifically, the material (material) thereof is a vegetable material or an animal material. The length of the wire 51 is equal to or longer than the length of the shaft 31. The wire rod 51 is arranged along the shaft 31, and its distal end (one end) is fixed to the proximal end 34 of the linear portion 32. The material of the wire rod 51 may be another material such as a metal material or a resin material. Further, in FIGS. 12 (a) and 12 (b), for convenience, each wire rod 51 is shown by a broken line (dotted line) (the same applies to FIG. 13 described later).

As shown in FIG. 12B, when each wire rod 51 is pulled to the proximal side, each linear portion 32 is pulled to the proximal side accordingly, and as a result, the proximal end portion 34 of each linear portion 32 is a shaft. You can get closer to 31. Specifically, in this case, the entire linear portion 32 is brought close to the shaft 31, and each linear portion 32 is in a state of extending along the shaft 31. Therefore, in the present balloon device 50, each wire rod 51 is pulled to the proximal side so that each linear portion 32 can be inserted into the inner tube 26 together with the shaft 31.

Next, the operation of the balloon device 50 described above will be described with reference to FIG. FIG. 13 is an explanatory diagram for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 50 and the work of removing the balloon device 50 from the body after the expansion. ..

First, by pulling each wire rod 51 to the proximal side, each linear portion 32 of the balloon device 50 can be inserted, and in that state, the balloon device 50 is introduced into the inner tube 26 of the balloon catheter 20. After the introduction, the shaft 31 is pushed to the distal side, and as shown in FIG. 13A, each linear portion 32 is led out to the distal side from the distal end opening of the inner tube 26.

Next, stop pulling each wire 51 to the proximal side and relax each wire 51. As a result, as shown in FIG. 13 (b), each linear portion 32 is in a natural state (state in FIG. 12 (a)), and the proximal end portion 34 of each linear portion 32 is separated from the shaft 31.

Next, as shown in FIG. 13 (c), each linear portion 32 is arranged on the outer peripheral side of the balloon 23 by pulling back the shaft 31 toward the proximal side. In this case, since the proximal end portion 34 of the linear portion 32 is separated from the shaft 31, each linear portion 32 can be easily arranged on the outer peripheral side of the balloon 23. When arranging each linear portion 32 on the outer peripheral side of the balloon 23, the wire rod 51 fixed to the proximal end portion 34 of each linear portion 32 is pulled toward the proximal side on the outer peripheral side of the balloon 23. become.

Next, as shown in FIG. 13 (d), the lesion 38 is expanded by inflating the balloon 23. As a result, each linear portion 32 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger.

Next, as shown in FIG. 13 (e), the balloon 23 is brought into a contracted state. Then, by pushing the shaft 31 toward the distal side, each linear portion 32 is positioned distal to the inner tube 26 from the outer peripheral side of the balloon 23. After that, each wire rod 51 is pulled toward the proximal side so that each linear portion 32 can be inserted.

Next, as shown in FIG. 13 (f), each linear portion 32 is introduced into the inner tube 26 by pulling the shaft 31 back to the proximal side. In this case, the linear portions 32 are introduced into the inner tube 26 while the linear portions 32 are maintained in an insertable state by pulling the wire rods 51 to the proximal side. Then, in the introduced state, the shaft 31 is pulled toward the proximal side to remove the balloon device 50.

Here, when each linear portion 32 is introduced into the inner tube 26, since the proximal end portion 34 of each linear portion 32 is brought close to the shaft 31, it is easy to introduce each linear portion 32 into the inner tube 26. It has become. Further, when the linear portions 32 are introduced into the inner tube 26, the linear portions 32 are in a state in which they can be inserted, so that the linear portions 32 can be more easily introduced into the inner tube 26.

According to the configuration of the present embodiment described above, the balloon device 50 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first to third embodiments. Therefore, when the balloon device 50 is introduced into the body, it is possible to prevent the linear portion 32 from damaging the tube wall in the body.

[Other embodiments]
The present disclosure is not limited to the above embodiment, and may be implemented as follows, for example.

(1) In the second embodiment, suction members 36 and 37 (magnetic materials) that suck each other by magnetic force (corresponding to suction force) are used as the suction member, but electrostatic force (suction force) is used as the suction member. You may use a suction member that sucks each other by magnetic force (corresponding to suction force) or electromagnetic force (corresponding to suction force). In this case, by applying (supplying) a current (corresponding to a factor that generates suction force) to each suction member from an external power source, that is, by energizing each suction member via wiring or the like, the above suction members are subjected to the above. It is conceivable to generate the electrostatic force and the above-mentioned electromagnetic force. Even in such a configuration, since a suction force can be generated in each suction member as needed, the same effect as that of the second embodiment can be obtained.

(2) In the third embodiment, the repulsive members 46 and 47 (magnetic materials) that repel each other by magnetic force (corresponding to the repulsive force) are used as the repulsive member, but the electrostatic force (repulsive force) is used as the repulsive member. Repulsive members that repel each other by electromagnetic force (corresponding to repulsive force) may be used. In this case, by applying (supplying) a current (corresponding to a factor that generates the repulsive force) to each repulsive member from an external power source, that is, by energizing each repulsive member via wiring or the like, the above-mentioned repulsive member is described above. It is conceivable to generate the electrostatic force of the above and the electromagnetic force of the above. Even in such a configuration, since a repulsive force can be generated in each repulsive member as needed, the same effect as that of the third embodiment can be obtained.

(3) In the above embodiment, the balloon device is provided with three linear portions, but the number of linear portions may be four or more, or may be two. Further, there may be one. Further, in the above embodiment, the plurality of linear portions are arranged at equal intervals (uniformly) in the circumferential direction of the shaft, but the plurality of linear portions are arranged at irregular intervals (non-uniform) in the circumferential direction of the shaft. May be good.

(4) The cross-sectional shape of the linear portion is not necessarily limited to that of the above embodiment. For example, in the first embodiment, the top 17 of the linear portion 12 has an obtuse angle, but as shown in FIG. 14A, the top 56 of the linear portion 55 may have an acute angle. In this case, it is possible to easily make a notch in the lesion portion.

Further, as shown in FIG. 14B, the arrangement surface 58 arranged on the outer peripheral surface of the balloon 23 in the linear portion 57 may be a curved surface that matches (follows) the outer peripheral surface of the balloon 23. In this case, the linear portion 57 can be arranged on the outer peripheral surface of the balloon 23 in a stable state. Further, in this case, since the entire arrangement surface 58 of the linear portion 57 can be arranged on the outer peripheral surface of the balloon 23, when the balloon 23 is inflated, the expanding force of the balloon 23 is suitably applied to the linear portion 57. I can tell. Therefore, an expanding force can be suitably applied to the lesion portion from the linear portion 57.

Further, the cross-sectional shape of the linear portion does not necessarily have to be a triangular shape, and may be another shape such as a quadrangular shape or a semicircular shape. In the example of FIG. 14C, the cross section of the linear portion 61 has a semicircular shape, and the linear portion 61 has a curved surface portion 62 (arc surface) that is convex outward in the radial direction of the shaft 11. doing. In this case, when the balloon device is introduced into the body, it is possible to further suppress the damage to the tube wall due to the linear portion 61.

(5) For example, as shown in FIG. 15, a protrusion 66 may be provided on the linear portion 65. In the example of FIG. 15, a plurality of protrusions 66 are provided on each linear portion 65 at predetermined intervals. These protrusions 66 project outward in the radial direction of the shaft 11, for example, spherically. In such a configuration, when making a cut in the lesion portion by the linear portion 65, it is possible to make the cut easier by using the protrusion 66 as a trigger.

(6) The form of the linear portion is not necessarily limited to that of the above embodiment. For example, the linear portion may be formed in a spiral shape. Hereinafter, a specific example thereof will be described with reference to FIG. 16A and 16B are side views showing the distal end side of the balloon device 70, where FIG. 16A shows the natural state of the linear portion 72 and FIG. 16B shows the insertable state of the linear portion 72. There is.

The balloon device 70 shown in FIG. 16A includes a shaft 71 and a linear portion 72 having one end 73 fixed to the distal end of the shaft 71. The linear portion 72 extends spirally from the one end portion 73 (hereinafter referred to as the fixed end portion 73) fixed to the shaft 71 toward the proximal side. The linear portion 72 has a spiral shape by being wound around the shaft 71. Further, the proximal end portion 74 of the linear portion 72 is a free end. In such a configuration, the linear portion 72 is spirally arranged on the outer peripheral side of the balloon 23.

Further, the linear portion 72 can be expanded and contracted in the axial direction of the shaft 71. When the linear portion 72 is pulled in the axial direction from the natural state (state of FIG. 16A), the linear portion 72 is in a state of extending along the shaft 71 as shown in FIG. 16B. NS. In this state, the linear portion 72 can be inserted into the inner tube 26 together with the shaft 71. Therefore, the state of the linear portion 72 is a state in which the linear portion 72 can be inserted. In the insertable state of the linear portion 72, the linear portion 72 is wound around the shaft 71.

In the above configuration, the balloon device 70 can be introduced into the inner tube 26 by making the linear portion 72 passable. Therefore, even if the linear portion 72 has a spiral structure, the balloon device 70 can be introduced into the body through the inner tube 26.

Further, in the balloon device 70 shown in FIG. 16, a wire rod 75 for performing an expansion / contraction operation of the linear portion 72 is fixed to the proximal end portion 74 of the linear portion 72. The wire rod 75 is made of, for example, a thread and extends proximally from a fixing site fixed to the linear portion 72 (proximal end portion 74). In FIGS. 16A and 16B, the wire rod 75 is shown by a broken line (dotted line) for convenience. In this case, as shown in FIG. 16B, when the wire rod 75 is pulled to the proximal side, the linear portion 72 is pulled in the axial direction of the shaft 71, and as a result, the linear portion 72 is inserted. It is considered possible. Further, when the pulling of the wire rod 75 is stopped, the linear portion 72 naturally contracts in the axial direction to be in a natural state.

(7) For example, as shown in FIGS. 17A and 17B, a connecting portion 82 connecting a plurality of (specifically two) linear portions 81 may be provided. In FIGS. 17 (a) and 17 (b), the shaft is not shown for convenience. The connecting portions 82 connect the linear portions 81 in an arc shape, and a plurality (specifically, three) of the linear portions 81 are arranged at predetermined intervals in the length direction of the linear portions 81. The connecting portion 82 is formed of an elastic material, and the linear portions 81 can be bent so as to approach each other (see the two-dot chain line in FIG. 17A). Further, the connecting portion 82 can be folded toward the linear portion 81 in the bent state as described above (see the two-dot chain line in FIG. 17B). In this case, since each linear portion 81 and each connecting portion 82 can be arranged along the shaft, each linear portion 81 and each connecting portion 82 can be inserted into the inner tube 26 together with the shaft. can.

(8) In the above embodiment, one end of the linear portion is directly fixed to the distal end of the shaft, but as shown in FIG. 18A, for example, one end of the linear portion 86 and the shaft 85 are far apart. A connecting member 87 may be interposed between the position end portion and one end portion of the linear portion 86 may be fixed to the distal end portion of the shaft 85 via the connecting member 87. In this case, the connecting member 87 is preferably formed of a material having relatively high strength such as a metal material or a hard resin. Since it is assumed that a relatively large load is applied to the connection portion between one end of the linear portion and the shaft when expanded by the balloon 23, the linear portion 86 falls off from the shaft 85. Etc. can be reliably avoided.

Although not shown, the connecting member 87 is provided with a hole that communicates with the tube hole of the shaft 85 and opens at the distal end, and the guide wire straddles the hole and the tube hole. G is inserted. Further, it is desirable that the angle formed by the linear portion 86 with the shaft 85 on the distal side is, for example, 30 ° to 120 °.

Further, as shown in FIG. 18B, as the connecting member 89, a member having a tapered shape on the distal side may be used. In this case, the connecting member 89 has a conical shape (tapered shape) whose outer diameter decreases toward the distal end on the distal side thereof. Since the distal end of the connecting member 89 constitutes the distal end of the balloon device, in this case the balloon device can be facilitated to be inserted into the inner tube 26.

(9) For example, a detachable portion may be provided to detachably fix one end (fixed end) of the linear portion to the shaft. In this case, after the linear portion is arranged on the outer peripheral side of the balloon 23, the linear portion can be removed from the shaft and placed in the body. Specifically, the configuration shown in FIG. 19 can be considered as such a detachable portion. In the example shown in FIG. 19, at the connection portion between one end portion 13 of the linear portion 12 and the shaft 11, suction portions 91 and 92 that attract each other by magnetic force are provided on the linear portion 12 and the shaft 11, respectively. .. Each of these suction portions 91 and 92 is made of, for example, a magnetic material, and the suction portion 91 is provided on the shaft 11 and the suction portion 92 is provided on the linear portion 12. In this case, when an external magnetic field is applied to each of the suction portions 91, 92, a magnetic force is generated in each of the suction portions 91, 92, and the one end portion 13 of the linear portion 12 is fixed to the shaft 11 by the magnetic force. .. Further, when the application of the external magnetic field to the suction portions 91 and 92 is stopped, no magnetic force is generated in the suction portions 91 and 92, whereby one end portion 13 of the linear portion 12 is disengaged from the shaft 11. As a result, in the example shown in FIG. 19, one end portion 13 of the linear portion 12 is detachably fixed to the shaft 11 via the suction portions 91 and 92. Therefore, in this example, the attachment / detachment portion is composed of the suction portions 91 and 92.

(10) The stent may be configured by including the removable linear portion described in (9) above. In this case, it is conceivable to realize such a stent with the configuration shown in FIG. That is, it is conceivable that the stent is configured to include each linear portion 81 and each connecting portion 82. In this case, one end of each linear portion 81 is fixed to the shaft via the detachable portion, whereby the linear portion 81 can be attached to and detached from the shaft. In this case, the stent (linear portion 81 and connecting portion 82) is introduced into the body through the inside of the inner tube 26, placed on the outer peripheral side of the balloon 23, and then expanded by inflating the balloon 23. After that, the stent can be placed in the body by removing each linear portion 81 from the shaft. As a result, when the stent is introduced into the body, it is possible to prevent the tube wall in the body from being damaged.

Further, in this case, since the stent can be introduced into the body while the balloon 23 is placed in the body, when a plurality of stents are placed in the body, the plurality of stents are inserted into the inner tube 26 while the balloon 23 is left in the body. It can be introduced into the body and indwelled through. That is, in this case, it is not necessary to perform the troublesome work of moving the balloon 23 in and out of the body each time each stent is introduced into the body, and the work can be easily performed when each stent is placed in the body. .. In particular, when the balloon 23 is taken in and out, the work of introducing the balloon 23 to the place where the stent is placed and aligning the balloon 23 is required, so that the work is expected to take a lot of time and effort. Therefore, even in view of this point, it is significant that the stent can be introduced into the body while the balloon 23 remains in the body.

As described above, when the stent is configured by including the removable linear portion 81, it is desirable that the cross section of the linear portion 81 has a circular shape. In this case, it is possible to reduce the risk of scratching the balloon 23 when the balloon 23 is inflated to expand the linear portion 81 (stent).

(11) In the above embodiment, the shaft is tubular and the tube hole is used as a lumen for the guide wire. However, when the guide wire is not required for introduction into the body, the shaft is made into a rod shape (solid state). It may be formed.

(12) In each of the above embodiments, the balloon device 10 of the present disclosure is used for the over-the-wire type balloon catheter 20, but the proximal end opening of the lumen 26a of the inner tube 26 is the axis of the balloon catheter 20. The balloon device of the present disclosure may be used for a so-called RX type balloon catheter located in the middle of the direction. Also in this case, the balloon device can be inserted into the lumen 26a of the inner tube 26 from the proximal end opening thereof, and the balloon device can be introduced into the body through the lumen 26a.

(13) The balloon device does not necessarily have to be introduced into the body through the inner tube 26 (in other words, the guide wire tube) for inserting the guide wire. For example, some balloon catheters have a tube other than the guide wire tube extending through the inside of the balloon. Therefore, in such a balloon catheter, the balloon device may be introduced into the body through the tube extending in the balloon.

(14) In the above embodiment, the case where the balloon device of the present disclosure is used for intravascular treatment has been described, but the balloon device of the present disclosure includes vessels other than blood vessels such as ureters, vas deferens, and lymphatic vessels. It can also be used for the treatment of.

Although this disclosure has been described in accordance with embodiments, it is understood that this disclosure is not limited to such embodiments or structures. The present disclosure also includes various variations and variations within a uniform range. In addition, various combinations and forms, as well as other combinations and forms that include only one element, more, or less, are within the scope and scope of the present disclosure.

10 ... Balloon device, 11 ... Shaft, 12 ... Linear part, 14 ... Proximal end, 15 ... Bending part, 15a ... Top, 20 ... Balloon catheter, 23 ... Balloon, 26 ... Inner tube as tube, 30 ... Balloon device, 31 ... Shaft, 32 ... Linear portion, 36, 37 ... Suction member constituting the closing means, 40 ... Balloon device, 41 ... Shaft, 42 ... Linear portion, 46, 47 ... Opening means A repulsive member, 50 ... a device for a balloon, 51 ... a wire rod as a closing means.

Claims (12)

1. A device for a balloon used in a balloon catheter comprising an inflatable and contractible balloon and a tube to which the balloon is attached to the distal end and extends through the interior of the balloon.
   The shaft inserted into the tube and
   One end is fixed to the distal end side of the shaft, the other end side extends proximally to the one end side, and a linear part arranged on the outer peripheral side of the balloon is provided.
   The balloon device is formed so that the linear portion extends along the shaft so that the linear portion can be inserted into the tube together with the shaft.
2. The linear portion is formed so that at least the proximal end portion is separated from the shaft in the natural state, and the linear portion is made into the insertable state by bending toward the shaft side from the natural state. Item 1. The balloon device according to item 1.
3. The balloon device according to claim 2, further comprising a closing means for bringing the linear portion closer to the shaft.
4. As the closing means, a plurality of suction members provided on the linear portion and the shaft, respectively, and sucking each other by suction force are provided.
   The balloon device according to claim 3, wherein each suction member generates the suction force by applying a generation factor that generates the suction force from the outside.
5. As the closing means, a wire rod fixed to the linear portion and extending toward the proximal side from the fixing portion is provided, and the linear portion is pulled toward the proximal side so that the linear portion is attached to the shaft. The balloon device according to claim 3, which is brought closer.
6. The linear portion has a bent portion that extends distally from the one end and is bent so that the other end side of the distal end extends proximally.
   The distal end is made up of the apex of the bend.
   The balloon according to claim 2, wherein the linear portion is bendable at the top portion, and the other end side is arranged along the shaft by the bending, so that the balloon is in a passable state. For the device.
7. The balloon device according to claim 6, wherein the linear portion has one end fixed to the distal end surface of the shaft.
8. The first aspect of the present invention, wherein the linear portion is in the insertable state in a natural state, and is arranged on the outer peripheral side of the balloon by bending toward a side away from the shaft from the natural state. Device for balloons.
9. The balloon device according to claim 8, further comprising an opening means for separating the proximal end of the linear portion from the shaft.
10. As the opening means, a plurality of repulsive members provided on the linear portion and the shaft, respectively, and repelling each other by a repulsive force are provided.
    The balloon device according to claim 9, wherein each of the repulsive members generates the repulsive force by applying a generating factor that generates the repulsive force from the outside.
11. The balloon device according to any one of claims 1 to 10, wherein the linear portion is a linear portion for forming a notch used for making a notch in a lesion portion in the body.
12. The balloon device according to any one of claims 1 to 11, further comprising a detachable portion for detachably fixing the one end portion of the linear portion to the shaft.

Images